Abicipar Pegol PALM Study Phase 2 Data in Diabetic Macular Edema (DME) Presented at 2016 AAO Annual Meeting
Molecular Partners AG (SIX: MOLN) announced that Tarek S. Hassan, MD, Professor of Ophthalmology at Oakland University William Beaumont School of Medicine and Senior Partner and Director of the Vitreoretinal Fellowship Training Program at Associated Retinal Consultants in Royal Oak, Michigan, presented the data of PALM, A Multicenter, Double Masked Phase 2 Clinical Trial Evaluating Abicipar Pegol (abicipar) for Diabetic Macular Edema (DME) at the American Academy of Ophthalmology Annual Meeting (AAO) 2016 in Chicago.
A total of 151 patients with DME (BCVA ≤75 and ≥24 letters) were enrolled. The efficacy of abicipar was demonstrated in all treatment groups. Abicipar 2 mg (Q8weeks and Q12weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (CRT) effects comparable with monthly ranibizumab, and with fewer injections over a 28 week period. The most common ocular adverse events were vitreous floaters and conjunctival hemorrhage in the abicipar arms. Intraocular inflammation occurred in 7, 5 and 4 patients treated with abicipar 1Q8, 2Q8 and 2Q12 groups, respectively and none with ranibizumab. These adverse events were mostly mild to moderate in severity, and resolved with treatment. These data support progression to phase 3.
Allergan is currently enrolling patients in a phase 3 trial for AMD using an updated formulation of
abicipar. Enrollment is progressing well and topline results are expected in 2018.